Dexmedetomidine or Clonidine Infusion for Prevention of Delirium After Open Heart Surgery

Launched by OSLO UNIVERSITY HOSPITAL · Aug 25, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether two medications, dexmedetomidine and clonidine, can help prevent delirium and cognitive decline in older adults after they have open heart surgery. Delirium is a sudden change in mental function that can happen after surgery, and the researchers want to see if these medications can reduce this risk. The trial is open to both men and women aged 70 and older who are scheduled for certain types of heart surgery that require a heart-lung machine.

To participate in the study, individuals need to be at least 70 years old and should be preparing for specific heart surgeries, such as bypass grafting or valve replacements. However, those with certain health issues, like severe heart problems or recent strokes, are not eligible. Participants will be randomly assigned to receive either one of the medications or a placebo (a substance with no active ingredients) and will be monitored closely by medical professionals. This research aims to improve care for older patients undergoing heart surgery, so they can recover better and experience less confusion or memory problems after their procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants are eligible to be included in the study only if all of the following criteria apply:
• • 1. Participant must be ≥70 years old at the time of signing the informed consent.
• • 2. Participant must be accepted for cardiac surgery with cardiopulmonary bypass. The surgical procedures may constitute 1) coronary bypass grafting, 2) tricuspid, mitral, or aortic valve replacement or repair, 3) surgery on the ascending aorta, and 4) the combination any of these procedures.
• • 3. Participant must be capable of giving signed informed consent.
• Exclusion Criteria:
• Participants are excluded from the study if any of the following criteria apply:
• • 4. Preoperative delirium
• • 5. Known hypersensitivity to the active ingredient or components of the product
• • 6. Bradycardia due to sick-sinus-syndrome, 2nd or 3rd degree AV-block (if not treated with pacemaker) or any other reason causing HR \<50 bpm at time of inclusion
• • 7. Uncontrolled hypotension
• • 8. Ischemic stroke or transitory ischemic attack the last month or critical peripheral ischemia
• • 9. Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines
• • 10. Left ventricular ejection fraction \< 40%
• • 11. Severe renal impairment (estimated GFR \<20ml/min) or expected requirement for renal replacement therapy
• • 12. Severe hepatic dysfunction (liver enzyme three times the upper limit of normal together with a serum albumin concentration below the normal reference limit)
• • 13. Reduced peripheral autonomous activity (e.g. spinal cord injury)
• • 14. Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
• • 15. Endocarditis or sepsis
• • 16. Pheochromocytoma
• • 17. Planned deep hypothermia and circulatory arrest
• • 18. Emergency surgery, defined as less than 24 hours from admission to surgery
• • 19. Previously included in this study
• • 20. Not speaking or reading Norwegian
• • 21. Any other condition as evaluated by the treating physician